Lumbar Spine SurgeryNCT05698914
Telehealth Mindfulness After Spine Surgery
A study testing Telehealth mindfulness-based intervention (MBI) and Telehealth Education in people with Lumbar Spine Surgery and Chronic Low-back Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Surgery, Chronic Low-back Pain, Postsurgical Pain
- What is being tested?
- Telehealth mindfulness-based intervention (MBI) and Telehealth Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2023to 11 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults
- Aged 18 years and older
- Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
- Scheduled for their first lumbar spine surgery
- Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
- Presence of back and/or lower extremity pain persisting for at least 3 months
- Access to stable internet.
- Able to participate in weekly, remote sessions with a study therapist for 8 weeks after surgery
Who cannot join
- Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
- Having surgery for the primary indication of a spinal deformity
- Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis (e.g. Schizophrenia, brief psychotic disorder, delusional disorder). Medication-induced psychosis is not exclusionary.
- Diagnosis of Alzheimer's disease or another form of dementia
- Traumatic Brain Injury (greater than mild severity)
Show all 10Show fewer
- History of bipolar disorder or dissociative disorder
- Active substance use disorder (in past month)
- Current Posttraumatic Stress Disorder (PTSD) symptoms (in past month)
- Active suicidal ideation with intent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions:
- Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?
- Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other?
Read more
Participants will be asked to do the following:
- Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
- Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
- Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education. Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).
Read the detailed description
This is a pilot randomized clinical trial comparing a telehealth mindfulness-based intervention (MBI) with a telehealth education intervention (EDU) for patients recovering from spine surgery. The procedures will be as follows:
- Enroll patients prior to lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment, enrollment, and screening will occur at a routine preoperative clinic visit or over the phone.
- Two weeks after enrolled participants complete surgery, they will be randomized in a 3:2 ratio to either MBI or EDU condition, respectively. Randomization will be stratified by chronic preoperative opioid use (yes/no). The randomization assignments will remain concealed from all study personnel until the time of randomization. The outcome assessor and surgical providers will remain blinded to participant study condition.
- Within four weeks of surgery, participants will begin the assigned intervention. The interventions will consist of meeting with an interventionist for eight, weekly one-on-one telehealth MBI sessions over an online telehealth platform. MBI sessions will led by a clinical psychologist and will be 75 minutes long (90 minutes for the first session). EDU sessions will be led by a physical therapist and will be 30 minutes long. Sessions will be audio recorded and monitored for fidelity.
- Participants will complete self-report assessments online prior to surgery, two weeks after surgery (pre-intervention), three months after surgery (post-intervention) and 6 months after surgery.
- Participants will complete quantitative sensory testing assessments of pain tolerance, pain threshold, and temporal summation of pain prior to surgery, two weeks after surgery, three months after surgery, and 6 months after surgery.
- Being tested
- Telehealth mindfulness-based intervention (MBI), Telehealth Education
- Keywords
- Mindfulness, Telehealth
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth mindfulness-based intervention (MBI)Behavioural
The telehealth MBI is adapted from Mindfulness-based cognitive therapy for chronic pain and consists of eight, weekly 75-minute individual sessions (90 minutes allotted for the first session) with a mindfulness interventionist delivering the intervention over telehealth (online with audio and video camera) in addition to the patient receiving their usual postsurgical care. Participants will begin the intervention after completing the 2-week postoperative assessment and within 4 weeks after surgery. Participants will be asked to practice skills between sessions approximately 20-40 minutes per day.
Telehealth EducationBehavioural
Participants will receive a written educational booklet at the time of randomization (within 2-4 weeks after surgery) and 8, weekly telehealth sessions lasting 30 minutes in addition to usual postsurgical care. The educational materials are reviewed individually with the participant during weekly telehealth sessions (online with audio and video camera) by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth mindfulness-based intervention (MBI) | Experimental | Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor Receives: Behavioral: Telehealth mindfulness-based intervention (MBI) |
| Telehealth Education (EDU) | Active comparator | Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist Receives: Behavioral: Telehealth Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Proportion of participants approached who are eligible and enroll in the study
Measured: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
Participant Study Retention
Proportion of participants who complete the study (6 month assessment)
Measured: 6 months postoperative
Session Attendance
Average proportion of sessions attended out of 8 sessions
Measured: Through 3 months postoperative
Intervention Satisfaction
Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10
Measured: 3 months postoperative
Home Practice Completion
Average days practiced out of days assigned practice (MBI group only)
Measured: Through 3 months postoperative
Secondary outcomes (18)
Pain Interference Short-form 8a
Pain Interference short-form 8a from the Patient Reported Outcomes Measurement Information System scale. Measures interference of pain over the past 7 days. Consists of 8 items with response options from 1 = not at all to 5 = very much. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates lower pain interference, or a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Bothersomeness
One item assessing how bothersome pain has been in the past 7 days from 0 = not at all to 4 = extremely. A lower scores indicates lower pain bothersomeness.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Back Pain Intensity
1 item assessing back pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Leg Pain Intensity
1 item assessing leg pain intensity on a scale of 0-10 over the past 7 days, described as pain when off medication or medication has worn off. Lower scores indicate less pain, or better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Anxiety Short Form 4a
Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing anxiety symptoms in the past 7 days (e.g. "I felt fearful") with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Lower scores represent lower anxiety, a better outcome
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Physical Function
Physical Function short-form 4a - Patient Reported Outcomes Measurement Information System. 4 items assessing physical function in the past 7 days (e.g. "Are you able to do chores such as vacuuming or yard work?") with response options from 1 = Unable to do to 5 = Without any difficulty. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. Higher scores represent better physical function, a better outcome
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Depression Short Form 4a
Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing depressive symptoms over the past 7 days (e.g. "I felt worthless) with response options from 1 = never to 5 = always. The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less depression, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Sleep Disturbance Short Form 4a
Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System scale. 4 items assessing sleep disturbance over the past 7 days (e.g. "I had difficulty falling asleep) with response options from 1 = not at all to 5 = very much (1 item reverse-scored). The total score is a T-score based on a population with mean score of 50 and standard deviation of 10. A lower score indicates less sleep disturbance, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Oswestry Disability Index
Assesses impact of pain on level of functioning in 10 areas (e.g. walking, sleep, social life) with 10 items with response options with scores 0 to 5. Total scores are calculated as a percentage, ranging from 0% to 100%. Lower scores indicate a lower level of disability due to pain, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Catastrophizing Scale
13 items assessing thoughts and feelings when in pain (e.g. "I become afraid that the pain will get worse" with response options ranging from 0 = never to 4 = all the time. Total scores range from 0 to 52 units on the scale. Lower scores indicate lower pain catastrophizing, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Self-efficacy Questionnaire
10 items assessing confidence in ability to do certain things despite pain (e.g. "I can enjoy things, despite the pain" with response options 0 = not at all to 6 = completely. Total scores range from 0 to 60 units on the scale. Higher scores indicate greater pain self-efficacy, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Perceived Stress Scale - 4
4 items assessing perceived level of stress in the past month (e.g. "In the last month, how often have you felt that you were unable to control the important things in your life?"), with response options ranging from 0 = never to 4 = very often (2 items reverse-scored). Total scores range from 0 to 16 units on the scale. Lower scores indicate lower perceived stress, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Tampa Scale for Kinesiophobia -13
13 items assessing fear of movement (e.g. "I'm afraid that I might injure myself if I exercise" with response options ranging from 1 = strongly disagree to 4 = strongly agree. Total scores range from 13 to 52 units on the scale. Lower scores indicate lower levels of kinesiophobia, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Five Facet Mindfulness Questionnaire - 15
15 items assessing 5 facets of mindfulness, including observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Response options range from 1 = never to 5 = always (7 items reverse scored). Total scores are an average of the sum of all items, ranging from 1 to 5 units on the scale. Higher scores indicate higher levels of mindfulness, a better outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Number of Participants Indicating They Currently Use Opioids
Participants were asked in one item "Are you currently taking an opioid medication?" Response options included "Yes" or "No." A response of Yes counted as 1 and No counted as 0 when calculating total frequency of participants reporting current opioid use.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Tolerance
The duration of time participants tolerated an inflated blood pressure cuff: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the time in seconds at which the participant indicated they could no longer tolerate the stimulus (inflated blood pressure cuff). Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if reached prior to the participant indicating to stop the task.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Threshold
Duration at which participants indicate a stimulus is experienced as painful: Using an ischemic task involving squeezing a dynamometer followed by inflated blood pressure cuff on arm, the point in seconds at which the stimulus (inflated blood pressure cuff) is first reported by the participant as painful. Scores could range from 0 seconds to 300 seconds, as the task was discontinued at 300 seconds if participants did not yet indicate that the stimulus was painful.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Temporal Summation of Pain
Using a punctate stimuli (von frey hairs of 100g and 180g of force to the finger), the difference between reported pain intensity during a single prick and the reported highest pain intensity during repeated brief pricks at a constant intensity. Pain intensity was measured on a scale of 0 to 100. The difference score was calculated by subtracting the pain intensity with single prick from the pain intensity with repeated pricks and could range from 0 to 100 units of difference on the pain intensity scale. Lower values are a more favorable outcome.
Measured: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start22 Feb 2023
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Carrie Brintz, Vanderbilt University Medical Center
- Investigators
- Carrie E Brintz, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698914
- Sponsor's protocol ID
- 221711
- Other IDs
- K23AT011569
- Status last verified
- May 2026
- First submitted
- 27 Dec 2022
- Last updated
- 13 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Telehealth Mindfulness Intervention After Lumbar Spine Surgery: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05698914
- Acronym / sponsor ID
- 221711
- Keywords
- Mindfulness, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Posted 13 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions:
- Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population?
- Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other?
Participants will be asked to do the following:
- Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
- Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery.
- Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education. Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).
Detailed description
This is a pilot randomized clinical trial comparing a telehealth mindfulness-based intervention (MBI) with a telehealth education intervention (EDU) for patients recovering from spine surgery. The procedures will be as follows:
- Enroll patients prior to lumbar spine surgery for a degenerative spine condition at the Vanderbilt Comprehensive Spine Center. Recruitment, enrollment, and screening will occur at a routine preoperative clinic visit or over the phone.
- Two weeks after enrolled participants complete surgery, they will be randomized in a 3:2 ratio to either MBI or EDU condition, respectively. Randomization will be stratified by chronic preoperative opioid use (yes/no). The randomization assignments will remain concealed from all study personnel until the time of randomization. The outcome assessor and surgical providers will remain blinded to participant study condition.
- Within four weeks of surgery, participants will begin the assigned intervention. The interventions will consist of meeting with an interventionist for eight, weekly one-on-one telehealth MBI sessions over an online telehealth platform. MBI sessions will led by a clinical psychologist and will be 75 minutes long (90 minutes for the first session). EDU sessions will be led by a physical therapist and will be 30 minutes long. Sessions will be audio recorded and monitored for fidelity.
- Participants will complete self-report assessments online prior to surgery, two weeks after surgery (pre-intervention), three months after surgery (post-intervention) and 6 months after surgery.
- Participants will complete quantitative sensory testing assessments of pain tolerance, pain threshold, and temporal summation of pain prior to surgery, two weeks after surgery, three months after surgery, and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth mindfulness-based intervention (MBI) | Experimental | Behavioral: Telehealth mindfulness-based intervention (MBI)Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor |
| Telehealth Education (EDU) | Active comparator | Behavioral: Telehealth EducationEight, weekly post-surgical educational sessions delivered one-on-one with physical therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English-speaking adults
- Aged 18 years and older
- Scheduled for a laminectomy and/or fusion at Vanderbilt Spine Center
- Scheduled for their first lumbar spine surgery
- Radiographic evidence of a degenerative condition including but not limited to spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis
Key exclusion criteria (10 listed)
- Microsurgical technique as the primary procedure (i.e. isolated laminotomy or microdiscectomy)
- Having surgery for the primary indication of a spinal deformity
- Having surgery secondary to pseudarthrosis, trauma, infection, or tumor
- Current/history of a primary psychotic or major thought disorder or hospitalization for reasons related to psychosis (e.g. Schizophrenia, brief psychotic disorder, delusional disorder). Medication-induced psychosis is not exclusionary.
- Diagnosis of Alzheimer's disease or another form of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth mindfulness-based intervention (MBI)The telehealth MBI is adapted from Mindfulness-based cognitive therapy for chronic pain and consists of eight, weekly 75-minute individual sessions (90 minutes allotted for the first session) with a mindfulness interventionist delivering the intervention over telehealth (online with audio and video camera) in addition to the patient receiving their usual postsurgical care. Participants will begin the intervention after completing the 2-week postoperative assessment and within 4 weeks after surgery. Participants will be asked to practice skills between sessions approximately 20-40 minutes per day. | Behavioural | Telehealth mindfulness-based intervention (MBI) |
| Telehealth EducationParticipants will receive a written educational booklet at the time of randomization (within 2-4 weeks after surgery) and 8, weekly telehealth sessions lasting 30 minutes in addition to usual postsurgical care. The educational materials are reviewed individually with the participant during weekly telehealth sessions (online with audio and video camera) by a physical therapist. | Behavioural | Telehealth Education (EDU) |
Primary outcome
Enrollment Rate
Time frame: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.
Proportion of participants approached who are eligible and enroll in the study
Participant Study Retention
Time frame: 6 months postoperative
Proportion of participants who complete the study (6 month assessment)
Session Attendance
Time frame: Through 3 months postoperative
Average proportion of sessions attended out of 8 sessions
Intervention Satisfaction
Time frame: 3 months postoperative
Proportion of participants reporting overall satisfaction levels greater than or equal to 7 out of 10
Home Practice Completion
Time frame: Through 3 months postoperative
Average days practiced out of days assigned practice (MBI group only)
18 secondary outcomes
Pain Interference Short-form 8a
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Bothersomeness
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Back Pain Intensity
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Leg Pain Intensity
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Anxiety Short Form 4a
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Physical Function
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Depression Short Form 4a
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Sleep Disturbance Short Form 4a
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Oswestry Disability Index
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Catastrophizing Scale
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Self-efficacy Questionnaire
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Perceived Stress Scale - 4
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Tampa Scale for Kinesiophobia -13
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Five Facet Mindfulness Questionnaire - 15
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Number of Participants Indicating They Currently Use Opioids
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Tolerance
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Pain Threshold
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Temporal Summation of Pain
Time frame: Preoperative, 2 weeks postoperative, 3 months postoperative, 6 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie E Brintz, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth mindfulness-based intervention (MBI) and Telehealth Education in people with Lumbar Spine Surgery and Chronic Low-back Pain, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Preoperatively, from when the potential participant is approached for recruitment until the time at which a potential participant is either eligible and consents to enroll in the study, or is ineligible or declines to enroll in the study, up to 2 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.